The COVID-19 pandemic triggered unprecedented increased demand for some medical devices, as well as significant disruptions to global medical device manufacturing and supply chain operations. The FDA is monitoring the medical product supply chain and working closely with manufacturers and other stakeholders to evaluate the risk of disruptions and to prevent or reduce their impact on patients, health care providers, and the health of the public at large.
On this page:
- Notifying the FDA of Device Supply Chain Availability Issues
- Medical Device Types to Help Determine Section 506J Notification Obligations
- How to Notify the FDA
- For More Information: Webinar Materials
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The CARES Act added Section 506J to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided the FDA with new authorities intended to help prevent or mitigate negative public health impacts of medical device supply chain disruptions “during, or in advance of, a public health emergency declared by the Secretary under section 319 of the Public Health Service (PHS) Act.”
The FDA issued an immediately in effect guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical devices that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information to help prevent or mitigate shortages during the COVID-19 public health emergency.
Under Section 506J, manufacturers of the following devices must notify the FDA of an interruption or permanent discontinuance in manufacturing:
- Devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery
- Devices for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency.
See Medical Device Types to Help Determine Section 506J Notification Obligations for a list of device types and corresponding product codes that FDA recommends manufacturers consider in determining whether they are required to notify FDA pursuant to Section 506J during the COVID-19 pandemic. This list represents FDA’s current understanding of the circumstances described above. This list is not exhaustive, and FDA intends to update this list as the COVID-19 pandemic evolves. The FDA will publicly announce any changes to this list.
For instructions on how to notify the FDA of an interruption or permanent discontinuance in manufacturing: during a public health emergency (under Section 506J of the FD&C Act), see Contact the FDA About a Medical Device Supply Chain Issue.
The FDA conducted a webinar on May 11, 2020 that provides more information and questions and answers on the guidance.
For more details on this webinar, including the printable slides and transcript, see Webinar - Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency.